Quality Assurance Specialist
San Mateo Metro Area, CA
Reporting directly to member of the QA leadership team. Leads or supervises execution of assurance activities for Science Unit quality and compliance program. Provides expert advice on relevant GLP quality and compliance, as well as lab GCP, HBS and GLS as required. Responsible for expert evaluation of risk, standards and quality principles associated with regulations and standards governing pre-clinical and bioanalytical research.
Advises management and gives general assistance in relation to compliance program / risk questions/issues.
May manage administrative or contracted staff.
Implements and maintains effective compliance program activities for GLP research as well as assurance of lab GCP, HBS and GLS, as required
Operationally executes second line of defense responsibilities (quality assurance assessments, auditing, investigations, assurance reporting, etc.) as a lead
Provides responsive and proactive quality and compliance advice to defined customers and effectively influence assigned area by being relevant GLP expert, as well as lab GCP, HBS (Human Biological Samples) and GLS (Global Laboratory Standard) as required; drives a culture that seeks to prevent non-compliance and poor quality
Assess need for/lead in facilitating the development of and monitoring of applicable CAPA plans
Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
Support driving and embedding a culture of ethics and integrity
Supports operational implementation of compliance objectives (aligned with Global Compliance strategy and objectives)
Performs key leadership support roles for regulatory inspections as assigned l Works with contract personnel or consultants to prepare, conduct and report assurance audits
Execute assurance and advisory activities for assigned GLP area, as well as lab GCP, HBS and GLS as required and computer systems validation.
Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena
Leads training for compliance colleagues and customers as required.
Education, Qualifications, Skills and Experience Essential:
Degree level education
GLP (21 CFR part 58)
Quality management (ie. auditing experience in the quality standards)
Experience in pharmaceuticals or a related industry
Knowledge of corporate governance, health care regulations, laws and standards
Excellent analytical, written and oral communications skills
Strong collaborative, partnering, and interpersonal skills
Strong ability to work independently
Basic project management skills
High ethical standards, trustworthy, operating with absolute discretion